Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
NCT ID: NCT01191060
Last Updated: 2019-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2010-10-31
2018-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Frontline Therapy in de Novo Multiple Myeloma Patients Under 65
NCT01206205
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
NCT01208662
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
NCT05257083
Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Plus Lenalidomide Maintenance in Multiple Myeloma
NCT02897830
S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT01668719
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
lenalidomide, bortezomib with ASCT
RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent)
Autologous stem cell transplant:
Melphalan: infused over two days (day -2 and day -1) or as a single infusion (day-2) according to institutional practice Re-infusion of PBSCs RVD q 21 days (2 cycles) Maintenance Lenalidomide q28 days (12 months)
Lenalidomide, Bortezomib
Lenalidomide Bortezomib Dexamethasone cycles:
Number of cycles: 5 cycles for arm B
Cycle length
Dosage:
* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
lenalidomide, bortezomib without ASCT
RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent) RVD q 21 days (5 cycles) Maintenance Lenalidomide q28 days (12 months)
Lenalidomide, Bortezomib
Lenalidomide/Bortézomib/Dexamethasone cycles:
Number of cycles: 8 cycles for arm A
Cycle length
Dosage:
* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lenalidomide, Bortezomib
Lenalidomide/Bortézomib/Dexamethasone cycles:
Number of cycles: 8 cycles for arm A
Cycle length
Dosage:
* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Lenalidomide, Bortezomib
Lenalidomide Bortezomib Dexamethasone cycles:
Number of cycles: 5 cycles for arm B
Cycle length
Dosage:
* Lenalidomide: 25 mg/day on days 1-14 of each cycle
* Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients diagnosed with multiple myeloma based on International Myeloma Foundation 2003 Diagnostic Criteria.
* Patients must have symptomatic myeloma with myeloma-related organ damage.
* Patients must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
* Age between 18 and 65 years at the time of signing the informed consent document.
* ECOG performance status \<2 (Karnofsky ≥ 60%)
* Negative HIV blood test
Exclusion Criteria
* Primary amyloidosis (AL) or myeloma complicated by amylosis.
* Participants may not be receiving any other study investigational agents.
* Participants with known brain metastases
* Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to study agents
* Platelet count \< 50,000/mm3 per µLwithin 21 days of initiation of protocol therapy. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria.
* ANC \< 1,000 cells/mm3 within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria.
* Hemoglobin \< 8.0 g/dL within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria.
* Hepatic impairment, defined a bilirubin \> 1.5 x institutional upper limit of normal (ULN) \> 2 mg/dL (Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible) and or AST (SGOT), or ALT (SGPT), or alkaline phosphatase \> 2 x ULN
* Renal insufficiency, defined as serum creatinine \> 2.5 mg/dl and/or creatinine clearance \< \<40 60 ml/min (actual or calculated). The Cockgroft-Gault formula should be used for calculating creatinine clearance values, and may be located in Section 4.2
* Respiratory compromise, defined as ventilation tests and with DLCO \< 50%
* Participant must not demonstrate with clinical signs of heart or coronary failure, or evidence of LVEF \< 40%. Participant must not have with myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
* Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not) infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements.
* Participant with previous history of another malignant condition, except for basal cell carcinoma and stage I cervical cancer
* Female participant who is pregnant or breast-feeding
* Inability to comply with an anti-thrombotic treatment regimen
* Peripheral neuropathy ≥ Grade 2 peripheral neuropathy on clinical examination within 21 days of initiation of protocol therapy
* Mental illness likely to interfere with participation in the study and Adults under juridical protection
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dana-Farber Cancer Institute
OTHER
Celgene Corporation
INDUSTRY
Janssen-Cilag Ltd.
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MICHEL ATTAL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CH du Pays D'Aix
Aix-en-Provence, , France
CHRU - Hôpital Sud Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Centre Hospitalier Argenteuil Victor Dupouy
Argenteuil, , France
Centre Hospitalier H.Duffaut
Avignon, , France
Centre Hospitalier de la côte basque
Bayonne, , France
Hôpital Jean Minjoz
Besançon, , France
Centre Hospitalier de Blois
Blois, , France
Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hôpital A.Morvan
Brest, , France
CHU Caen Côte de Nacre
Caen, , France
Centre François Baclesse
Caen, , France
CH René Dubos
Cergy-Pontoise, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
CH Chambéry
Chambéry, , France
Hôpital Antoine Béclère
Clamart, , France
Hôpital d'instruction des armées Percy
Clamart, , France
CHU d'Estaing
Clermont-Ferrand, , France
Pole Santé République
Clermont-Ferrand, , France
CH Louis Pasteur - Colmar
Colmar, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CHU Henri Mondor
Créteil, , France
CHRU Dijon
Dijon, , France
Centre Hospitalier Général - Dunkerque
Dunkirk, , France
Hôpital A.Michallon
Grenoble, , France
Centre hospitalier départemental - La Roche sur Yon cedex
La Roche-sur-Yon, , France
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, , France
Centre Jean Bernard
Le Mans, , France
Centre hospitalier Le Mans
Le Mans, , France
CHRU - Hôpital Claude Huriez
Lille, , France
CHU de Limoges
Limoges, , France
Centre hospitalier Bodelio
Lorient, , France
CHU - Hôpital Edouard Herriot
Lyon, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CH Meaux
Meaux, , France
Hopital E Muller
Mulhouse, , France
Hôpitaux de Brabois
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
CHRU - Hôtel Dieu
Nantes, , France
Hôpital Archet 1
Nice, , France
Hôpital de l'Archet
Nice, , France
Groupe Hospitalo-Universitaire Carémeau
Nîmes Cédex 9, , France
Institut Curie
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Saint-Louis
Paris, , France
Hôpital St-Antoine
Paris, , France
CH Saint Jean
Perpignan, , France
CHRU - Hôpital du Haut Lévêque
Pessac, , France
Centre Hospitalier Lyon sud
Pierre-Bénite, , France
CHRU - Hôpital Jean Bernard
Poitiers, , France
Centre Hospitalier de la région d'Annecy
Pringy, , France
Hôpital R.Debré
Reims, , France
CHRU - Hôpital de Pontchaillou
Rennes, , France
CHRU - Hôpital Sud
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Hospitalier Yves le Foll
Saint-Brieuc, , France
Centre René Huguenin
Saint-Cloud, , France
Centre Hospitalier Départemental - La réunion St Denis
Saint-Denis, , France
Groupe Hospitalier Sud Réunion
Saint-Pierre, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
University Hospital of Toulouse, Purpan
Toulouse, , France
CHRU - Hôpital Bretonneau
Tours, , France
Centre Hospitalier de Valence
Valence, , France
CH Bretagne Atlantique Vannes et Auray
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rosinol L, Hebraud B, Oriol A, Colin AL, Rios Tamayo R, Hulin C, Blanchard MJ, Caillot D, Sureda A, Hernandez MT, Arnulf B, Mateos MV, Macro M, San-Miguel J, Belhadj K, Lahuerta JJ, Garelik MB, Blade J, Moreau P. Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma. Front Oncol. 2023 Nov 2;13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023.
Noori S, Wijnands C, Langerhorst P, Bonifay V, Stingl C, Touzeau C, Corre J, Perrot A, Moreau P, Caillon H, Luider TM, Dejoie T, Jacobs JFM, van Duijn MM. Dynamic monitoring of myeloma minimal residual disease with targeted mass spectrometry. Blood Cancer J. 2023 Feb 24;13(1):30. doi: 10.1038/s41408-023-00803-z. No abstract available.
Langerhorst P, Noori S, Zajec M, De Rijke YB, Gloerich J, van Gool AJ, Caillon H, Joosten I, Luider TM, Corre J, VanDuijn MM, Dejoie T, Jacobs JFM. Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow. Clin Chem. 2021 Nov 26;67(12):1689-1698. doi: 10.1093/clinchem/hvab187.
Samur MK, Aktas Samur A, Fulciniti M, Szalat R, Han T, Shammas M, Richardson P, Magrangeas F, Minvielle S, Corre J, Moreau P, Thakurta A, Anderson KC, Parmigiani G, Avet-Loiseau H, Munshi NC. Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group. J Clin Oncol. 2020 Sep 20;38(27):3107-3118. doi: 10.1200/JCO.20.00461. Epub 2020 Jul 20.
Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M. Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Jun;61(6):1323-1333. doi: 10.1080/10428194.2020.1719091. Epub 2020 Feb 22.
Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, Arnulf B, Macro M, Belhadj K, Garderet L, Roussel M, Payen C, Mathiot C, Fermand JP, Meuleman N, Rollet S, Maglio ME, Zeytoonjian AA, Weller EA, Munshi N, Anderson KC, Richardson PG, Facon T, Avet-Loiseau H, Harousseau JL, Moreau P; IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017 Apr 6;376(14):1311-1320. doi: 10.1056/NEJMoa1611750.
Dunavin NC, Wei L, Elder P, Phillips GS, Benson DM Jr, Hofmeister CC, Penza S, Greenfield C, Rose KS, Rieser G, Merritt L, Ketcham J, Heerema N, Byrd JC, Devine SM, Efebera YA. Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma. Leuk Lymphoma. 2013 Aug;54(8):1658-64. doi: 10.3109/10428194.2012.751528. Epub 2012 Dec 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09 110 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.